FDA.reportPublic FDA data

Application 076625

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-028Luteralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-028Luteralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-028Luteralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-028Luteralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
53002-1632Luteralevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1632Luteralevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39512SUPPL2012-10-22